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June 08, 2010

AMP v. USPTO: What Everyone Else Is Saying - Part II

In March, the District Court for the Southern
District of New York found
the claims of
several of Myriad Genetics patents (directed to the BRCA1 and BRCA2 genes) invalid, ruling in favor of the plaintiffs in Association of
Molecular Pathology v. U.S. Patent and Trademark Office (see "Round One Goes to the ACLU").Following the decision, we discussed
the parties' reaction to the outcome (see "AMP v. USPTO: What the Parties
Are Saying About the Decision"),
and then examined what others were saying or reporting about the decision (see
"AMP v. USPTO: What Everyone Else Is Saying").With the deadline for appealing the lower court's decision less than two weeks away (defendants have until June 18 -- or 60 days
after judgment was entered on April 19 -- to file a notice of appeal), we take a second look at what others have been saying about the decision over the past two months.

Whether patents are for genes encoding therapeutic proteins such as
insulin and growth hormones, antibodies such as Herceptin® and Rituxan®, or
mutated genes that are indicative of breast or ovarian cancer, precluding
patents on this subject matter will halt the forward progress that has been
made in the biotech industry over the past 30 years since [Diamond v.]
Chakrabarty was decided.

The article suggests that "[i]n essence, the
lawsuit challenges the entire field of gene patenting when it seems that the
true question is whether our healthcare system provides access to specific
genetic tests (or therapeutics)."If plaintiffs ultimately prevail, the article asks whether the
plaintiffs "next go after Genentech because it has patents and a market
for Herceptin for Her2 positive breast cancer; Pfizer and AstraZeneca, for
their patents on statins; Biogen-Idec for Rituxan for the treatment of certain
types of B-cell non-Hodgkin lymphoma; or Bristol-Myers Squibb, which sells
Erbitux?"With respect to the
impact the case might have on investment, Robert More of Frazier Healthcare
Ventures observes that he has "seen quite a few technologies over the
years that would be of potential great benefit to patients, but the
intellectual property was simply not there to support protecting the product
from fast followers in the market place," adding that "because of the
enormous sums of money required to discover, develop, test, and approve
anything in the healthcare sector, quite aside from the time it takes, IP is
critical."Mr. More also
suggests that "20 years or less of exclusivity . . . is a small price for
us to pay for innovation."

• In "How Gene Patents Harm Innovation,"
Forbes.com declares that the decision marks "the first battle in which the
future of medicine confronted the past -- and the future won."The article argues that:

Far from hurting biotech innovation, eliminating pure gene patents will
greatly speed innovation in the biotech sector.Instead of tying up basic genetic information with patents,
the biotech industry will have to become more like computer industry.It will compete on the quality of its
machines and software algorithms, not by making scientific discoveries and
locking up the information for decades with a patent. Numerous high-tech gene
companies will be able to flourish thanks to superior technology.

• In "Who owns your genes?" a
San Francisco Chronicle editorial predicts that the case will eventually reach
the Supreme Court and advises that "[t]he high court should strike it
down," arguing that "[g]enes are the common property of humanity, not
the private fiefdoms of individual companies."

• In "End of Gene Patents Will Help Patients,
Force Companies to Change,"
WIRED opines that "[w]hen you went to sleep last Sunday night [March
28th], 20 percent of your genome belonged to a researcher or company[, and o]ne
day later, following federal district court judge Robert Sweet’s ruling, it
belonged to you."Discussing
the plaintiffs' case, the article states that:

Beyond the absurdity of gene patents -- imagine patenting gold, the
human arm, or gravity -- [plaintiffs] said that patents had hurt patients,
stifled business and stunted research.Myriad’s monopoly prevented women from getting second opinions on their
breast-cancer gene tests.More
broadly, existing gene patents dissuaded researchers from studying sections of
the genome that were already claimed, and high licensing fees discouraged
would-be entrepreneurs.

In the article, 23andMe CEO Linda Avey states that
"[m]y hope is that this ruling stands and companies will need to actually
innovate and create new advances based on genetic findings, not depend[] on
sole access to them."If the
decision stands, she predicts that "[r]ather than relying on obscure
patent language and legal strategies, companies will need to develop products
that are competitively positioned."

• In "The absurdity of patenting genes,"
The Guardian offers a few reasons "why gene patents like [Myriad's] are
stupid."While acknowledging
that "[p]atents are a sensible idea, because people are more likely to
invest in innovation if they believe it will give them a competitive advantage
over other people, and because patents allow people to share their discoveries
safely, instead of monetising their advantage by keeping a discovery
secret," the article states that "patents also act as a barrier to
innovation, and gene patents bring these disadvantages [sic] into stark
relief."On the
"chilling effect" gene patents alledgedly have on clinical activity and research,
the article states that:

Almost all basic science research on the BRCA1 breast cancer gene over
the past 12 years has infringed Myriad's patent, and although the company has
tended not to go after basic science researchers, they have never promised that
they won't in the future, so this academic research on a major risk factor for
a major killer -- the most common cancer in women worldwide -- continues only
with Myriad's indulgence, making it risky work.

In my mind I just cannot fathom the time, effort and cost it took us to
try to get the testing to where it is today.Most of the plaintiffs in this case are academic centers,
and I just cannot see an academic center spending hundreds of millions of
dollars employing a thousand people all to try to promote the science.

• Finally, in "Elements of humanity should not be
patented,"
a St. Petersburg Times editorial states that "for years companies have
been turning our genes into products, patenting them and keeping people from
accessing their own genetic information," and opines that "[t]hese
patents on nature should never have been granted."The article notes that "[t]he
[District Court's] ruling has thrown the biotech industry into a tizzy,"
but declares that "the judge's reasoning is airtight."On the issue of innovation, the piece
states that:

Biotech firms argue that they need the patents to spur investment in
study.But this is a red
herring.There are all sorts of
ancillary parts of genetic research that are subject to patent and hugely
profitable.Instead, the ruling
will be a boon to genetic science and public health. Competition in the field
of genetic testing will bring costs down, giving access to more people to know
what disease proclivities they carry.

Comments

It might be surprising at first that so many academic/tech journals should be toeing the communal line. After all, quite a few scientists depend upon corporate biotech investments for their jobs. I suspect it is another example of "state capture", where the hand that is feeding you is the government and not private industry, and opinions conform. Does anyone know whether there are more people employed in the biotech field under Government grants than by industry?

I particularly like the comment that the biotech sector should be more like the IT sector that does not depend on patents for protecting innovation. Surely, this commentator is unaware that the IT sector patents more than the life sciences sector.

Also, what happens when the administration changes and federal grants are cut? Then there is no federal money to keep academic labs running.

Oh well, leeches are always a good alternative to modern medicine and not subject to patent protection.

EG I see a lot of Kool-Aid drinking in your comments but I don't point it out each and every chance I get.

Either way, it is nice to see that your ordinary folks can see through the legal absurdities being used to justify at least some of the most egregious instances of "patentable subject matter" in today's modern times.

I think the CAFC should take note of what the public at large regards their patent laws to cover and what are not covered. Furthermore, I think that should become more and more important in the years to come. Patent lawls were plainly never intended for things like genes, methods of exercising cats with FRIGGIN' LASER BEAMS on or off of their heads, protecting machines merely in terms of the functionality which they are performing, etc. etc., the list goes on and on. The bar should have put a stop to this nonsense years before I was born.

The fact of the matter is that the patent laws were drafted in simpler times, and do not take into account many subtleties of the ramifications for giving patent protection to many of the things regarded by some attorneys today as patentable. Or, in other cases simply haven't been properly maintained to be properly taking those subtleties into account. Take for instance the patenting of plants under the utility patent act. I just read that decision the other day and there were only 3 judges with their thinking caps on that day. Congress enacted the utility act in concert with the plant act to replace a previous "all in one" act that made specific exceptions to the protection that plants could recieve and how patents on plants could be enforced. The plant act retained nearly the identical exceptions, yet, in its infinite "wisdom" the court decided that plants are "productslol". Right. Give me a break you frakkin previously employed by, and big business sellout judges on that court. You note that the judges thinking clearly that day had the least ties to the industries standing to gain from that decision.

You'll note that when the system first started out it was at its purest, but as the years progressed the patent jurisprudence has been increasingly tainted throughout the years due to these types of things, and it's time for the courts or congress to clean up the mess.

I would argue the opposite. As an American, I have the right to petition my government for whatever rights and privileges I think I am entitled to.

Regarding the cat exerciser, there is a distinction between what is patent-eligible and what is patentable. For the first, the question is whether exercising cats with a laser pointer is a "method" under the statute. Seems to be. Then is it useful? The cat (and her owner) probably think so, and let's assume that, cats being recalcitrant beasts, finding a method that they can't resist is really useful. Then, is it new? Any prior art? Even anecdotal? No, OK then. Finally, we get to the obviousness prong, and there you may have a point. But before the first person showed it will work (and, remember, you don't have any prior art), it isn't evident that pussycat will care about a moving light.

So it seems the cat laser-pointer method is both patent-eligible and patentable. What's your beef? I assume it is because you have the attitude that only "important" inventions should be patented. The problem with that is we need someone to decide which ones are important and which ones are not. Since by definition we don't always know what will be important in the future (and I'm sure you have read the in retrospect hilarious statements from the past about cars, planes, and other inventions that "will never catch on"), making these predictions about the future is problematic at best.

Now I agree that the cat exerciser is trivial, but what is the harm? People copyright the drivel they privately publish each year, and except for some unwanted Christmas presents and a box or two of these publications moldering in the garage, no one cares. I realize that one difference is that copyrighted material isn't examined, but if it is efficiency you want, change what the Office charges. The really vain cat patentee might even pay all the maintenance fees, and then the Office has a net benefit (with which, among other things, they pay you).

And do you think Mr. Cat Exerciser is going to sue anyone on this patent? Thus, no societal problems or penalties.

In short, there really is no good basis for straying from the principle that "everything under the sun made by man" should be patent-eliglble. You want to say something is unpatentable, find some prior art.

Thanks for the comment. Since EG started it, I won't chastize you for the ad hominem, but remember we try to stay civil here.

One more thing. A plant as it grows in nature is not patentable. However, the PPA and the PVPA are directed to plants that either do not grow (under the PVA they are non-productive) or otherwise need human intervention. So strictly-speaking they also require (quite literally) the "hand of man."

And remember, the reason these two Acts were passed was that they provided limited (1/2 the term of a utility patent) time protection for an American industry. Remember, iPods not Walkmans. Isn't that hard to see the benefit.

"For the first, the question is whether exercising cats with a laser pointer is a "method" under the statute. Seems to be. "

You needed to say "seems to belol". Then maybe you'll read the footnote in Bilski from the majority relating a USSC decision reminding us that "method" is simply code for "art" in patent speak in our 1952 act. Try your "analysislol" again considering that.

And no, I'm not concerned about 102/103 in this dicussion. This is a 101 day.

"What's your beef?"

My beef is that you don't see a lot of "method of exersizing a cat with an extra long belt" patent from 1819 (hopefully I didn't randomly pick a year where we had no PO) because back then they'd throw it out immediately as not being connected even loosely with the useful arts, or an "art" at all.

My beef is also that patent buffs like yourself seem to either purposefully ignore the history of patents, or haven't bothered yourself to learn about it. And I find the later a bit hard to believe, so we're left with the former. And that makes you look rather bad.

"Now I agree that the cat exerciser is trivial, but what is the harm?"

The harm is that these kinds of trivial nonsense are sometimes associated with business and people get sued for a lot of money over something that should never have issued, indeed, not only should have never been issued, but shouldn't have even been considered in the "issuable" category. It's basically government sponsored harassment. See for instance the late claims about a paradigm. I wonder how many tens of (hundreds of?) thousands of dollars were spent invalidating that nonsense? How many cures for cancer could we have had with that money spent to tell some mor on that he's a mor on, hmmm Kev?

Some of the harm in the instant case happened to be that women would have their breasts chopped off on Myriad's say so alone. And I like womens having all their breasts, so I was indirectly harmed as well. You probably were too if you'd admit it to yourself.

By the by, you'll also never see me lamenting the death of medical diagnostic claims, you didn't see a whole lot of that nonsense back in 1819 either did you? But yet they did have doctors, and they were coming up with new diagnostic methods. I wonda ware all tha patentz couda gon eh? I'll tell you where they went, if there were any they went into the abandonment pile, never to be published. Back then they realized that the patent system was to encourage the making and using of devices etc. for use in those kinds of diagnostics. Not just the diagnostic itself.

You know what would be awesome? If we still had all those old apps and file histories, and congress could pass a lawl stating that either all the apps, or at least a select number of apps would be published 100 years after they were abandoned just so that the patent system could have greater clarity in what kinds of things didn't make the cut and why. I think that many of you wouldn't bother with your nonsensical "belieflols" if you had a more proper and crystal clear historical perspective.

"In short, there really is no good basis for straying from the principle that "everything under the sun made by man" should be patent-eliglble."

Except for the whole "promote the Useful Arts" thing. Oh, right, that. Oh, and next time quote the whole quote, in context, it doesn't support your position quite as well as you seem to think it does.

"A plant as it grows in nature is not patentable. "

A plant as it grows in my garden shouldn't be patentable save under the statute explicitly written for plants. Stating otherwise is both lolable by everyone and blatantly a corrupt interpretation of the lawl. But how does congress correct this, save by some stu pid sounding language? Do they just add: "Hey, no, we really mean products, machines, compositions of matter, and methods, not plants, tards, we wrote another section for those" to the end of 101? I suppose they'll have to at some point since the judiciary gave their brains the day off. Of course that day won't come until a sufficient number of vocal/powerful people are being scre wed. Why? Because congress is too busy worrying about gay people getting married/into the military, killing people in afghanistan, and all manner of other nonsense that they have no business looking into anyway, or doesn't matter one bit to solve something that is cut and dry and easily remedied.

"However, the PPA and the PVPA are directed to plants that either do not grow (under the PVA they are non-productive) or otherwise need human intervention. So strictly-speaking they also require (quite literally) the "hand of man.""

What does that have to do with the fact that the other act(s) other than the utility act were passed to cover plants whereas the utility one wouldn't? Nothing that I can see.

Fact of the matter is, like it or not Kev, patent jurisprudence could be just as well renamed patent jurislolprudence in the last 50 years.

Anyway, the matter at hand is gene patents and how the popular media has picked up on their absurdity. Good for them. I hope they write their congress people to get to crackin' on some patent lawls that will reign in the patent lawlyer's shinanigans they've been playin' here a lately.

By the by, did you see the 32 year unemployed, live at home, congressperson candidate that won the dem primary in SC without hardly campaigning at all? He just paid 10k dollars and won the primary lol. Against another dude that spent 186000 on his campaign no less. I totally wish I could do that here in VA.

The only thing "egregious" I see is Judge Sweet's ruling in this case which is factually incorrect and legally flawed. Sweet's opinion shows he either doesn't understand the "product of nature" doctrine or he's manipulating the precedent, including mischaracterizing In re Bergy which supports the patent-eligibility of isolated gene subject matter. I know because I wrote on the "product of nature" doctrine before you probably were born, and Sweet frankly doesn't know what he's talking about. Plus relying on the "machine or transformation" test in Bilski to take down the method claims was an ill-advised move by Sweet in my opinion.

Kevin: Sorry if you viewed my initial comment as an "ad hominem." I'm simply calling these articles as I see them. Also, I've had plenty of verbal vitriol hurled at me for daring to take the position that isolated genes are patent-eligible; my reference to "Kool-Aid" drinking is tame by comparison.

"I know because I wrote on the "product of nature" doctrine before you probably were born, "

So you've been part of the problem, rather than the solution to this nonsense since before I was born. Impressive that you could manage to hold on for this long. Without brave souls such as yourself causing trouble maybe things would be fixed by now.

"I'm simply calling these articles as I see them. Also, I've had plenty of verbal vitriol hurled at me for daring to take the position that isolated genes are patent-eligible;"

Let's deal with the substance first. No one will ever be sued on the cat exercise patent. Period. So the patent on how to use a backyard swing, or how to propose to your fiance, or this cat one are vanity publications - never going to be a problem. So let's not get our undies in a twist about them.

As to the question of the difference between 1819 and today, remember that after Justice Scalia contemptuously asked about patents on "horse whispering" (like you, presuming that "trivial" patents were not granted in the 19th century), pundits were happy to find just such patents granted in the the 1800's. Why - because the ability to handle a horse was an economic necessity until the horse was displaced with the automobile about 100 years ago. Since you have the vast resources of the USPTO at your disposal (and clearly have the time and the interest), do you have the courage to go back and look at those early patents to see if they pass whatever patent-eligibility test you may like to impose? We'll see.

A problem with the kind of analysis you propose - "well, THAT can't be patentable, surely!" - is that it is objectively standardless - whether something should be eligible for patent depends on a particular individual's beliefs. Now, I'm sure that sentiment arises in the PTO all the time, but it is better to do what I suggested - find some prior art - than to just decide that something shouldn't be patented because you don't think so.

If we do want to think about an objective standard, the one the Supreme Court enunciated in Chakrabarty is as good as any - ANYTHING made by man that is not a natural phenomenon (per Chief Judge Rader, applications of natural phenomena can be patented, but not the phenomenon itself) or a law of nature or an idea (again, the physical embodiment or tangible product of an idea certainly can be).

Finally on the substance, the reason the PVA and the PPVA were enacted was to protect inventions that could not be protected by utility patents, not for 101/patentability reasons but because they could not satisfy 112.

Now, for the last time (since we don't have the time to police your posts), people who disagree with you are not morons, judges haven't been bought by big business and Members of Congress don't pass legislation thoughtlessly - not that these things are impossible, but saying them is a substitute for serious and productive discussion of what we think are serious matters. You are entitled to your opinion, and to your idiosyncratic way of expressing it, but that privilege ends when we digress into the kind of post upthread. There are plenty of other blogs that think this manner of argument is appropriate; we do not. Please don't practice it here.

2. The things you recite about the plant acts are irrelevant to whether or not plants were covered under the previous version of 101 or not. They weren't, that wasn't even contested in that case. Yet, the court decided that now they should be.

3. I perhaps misspoke about the judges, I didn't mean to imply that they were on the take. I meant to imply that they were sympathetic to their previous industries. Perhaps I used the wrong words.

4. I don't see why you think 101 should be objective where 103 and 112 aren't. See KSR and Ariad. Furthermore, in so far as it can be objective I believe that it is and that my interpretation is. All it requires is for the reader to not actively attempt to pervert the words of the constitution/statute and you will arrive at what is patentable subject matter save for those judicially excluded things. Indeed, this exersize might be easier for a random [deleted] off the street to perform than for a patent attorney to perform.

5. People who disagree with me may or may not be [deleted]. In fact, it is in the definition. I'll try to be nice though since you insist.

6. Congress doesn't capriciously/thoughtlessly pass laws? TARPLOLOLOLOLOLOLOLOL! Not only was it thoughtless, nobody even read the whole thing! They voted for an idea Kev, not legislation. They voted for what people told them would save the econ and they didn't care what it said. Now look Kev, I don't mean to diss congress, indeed, I think they're as thoughtful as they can be expected to be. I have in fact "played" legislator in the local town council and at the general assembly o VA, as well as having observed both of the real thing, and I know the types of tough calls they face and how they go about facing them, or being thoughtful about them. Congress is no different, save for an extra "political" aspect that is missing from local politics. But regardless of whether you're right or not about them being thoughtful you've got to be kidding me if you think that congress foresaw gene patenting in 1952. Or that they foresaw the courts about-facing on whether or not 101 would cover plants. I bet if you were a lawyer back before that case you'd have told me hands down that 101 didn't cover plants. Fact is, it may very well be time for an update straight from those "thoughtful" people in congress.

"This is not to suggest that § 101 has no limits or that it embraces every discovery. The laws of nature, physical phenomena, and abstract ideas have been held not patentable. See Parker v. Flook, 437 U.S. 584 (1978); Gottschalk v. Benson, 409 U.S. 63, 67 (1972); Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130 (1948); O'Reilly v. Morse, 15 How. 62, 112-121 (1854); Le Roy v. Tatham, 14 How. 156, 175 (1853). Thus, a new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter. Likewise, Einstein could not patent his celebrated law that E=mc; nor could Newton have patented the law of gravity. Such discoveries are "manifestations of . . . nature, free to all men and reserved exclusively to none."

I totally agree with this statement. Under it, an isolated nucleic acid sequence encoding a protein is patentable.

"I totally agree with this statement. Under it, an isolated nucleic acid sequence encoding a protein is patentable."

First I'm not convinced that you do totally agree with that statement. Or at least you don't totally agree with the rational behind it.

I have my doubts as to whether or not isolated nucleic acid sequences, whether encoding a protein or not, are patentable subject matter. I wonder, do you believe that a slightly refined version of the mineral referred to by the court is patentable subject matter? I wonder further if the USSC had happened to say "Thus, a new gene discovered in a human" in their off the cuff remark, rather than "Thus, a new mineral discovered in the earth" if we'd be having this dicussion. My guess is, we wouldn't.

Seems like I may have brought this up before, but you avoided making any kind of distinction between a newly isolated mineral from the earth and a newly isolated gene from a human. I believe that rather than address that perfectly good point, you retreated into something akin to: "but [but] if we go with that rational then all these purified adrenaline etc. products aren't patentable either!". To which I believe I responded, "careful Kev, no need to invalidate more than one big chunk of your art at a time".

We've been down this road, so unless you either believe the slightly refined mineral is patentable subject matter or have some reason to otherwise distinguish between the two situations presented there then I believe we're at an impasse.

I enjoyed your Myriad analysis at the CBA Friday because I am really tired of the "should genes be owned" debate. I appreciate your insider take on our future living with Myriad and have three comments.

First, you mentioned that trade secret protection for gene chips is viable because chip TS is hard to reverse engineer, and, consequently chip companies will resort to TS without gene patents. However, if chip layouts cannot be reverse-engineered, a company would have an incentive to pick TS over patents because of a potentially infinite duration, regardless of whether gene patents are available. In that sense, Sweet's decision appears to be a red herring.

My second comment relates to your observation that the heart of gene chip technology lies in getting the right combination of genetic information that is predicative of a phenotype. So even if Sweet's judgment stands (that an isolated cDNA sequence is not patentable), can't we still patent a novel combination of genetic information (and the placement of such information on a chip) that has a particular target (such as responsiveness to a chemo cocktail, a propensity for prostate cancer, etc)?

Third, I wonder if you are underestimating market forces and our ability to invent in the chip area when you said all basic technology in this area has been invented and will run out of patent soon. It seems to me that a company can always invent and patent a faster platform, with less false positive and negative, more sensitive and more information, and charge people a patent premium for that product. That's the case with semiconductors and the hardware industry so why wouldn't the same economics work in the DNA chip area?

Thanks for reading and I will make sure to subscribe to the feed to make your partner happy.